Drugs
Eighty-eight patient- and disease-focused organizations say they support FDA for recognizing the need for a central Office of Patient Affairs to coordinate opportunities for patient involvement in medical product development and regulation at the agency. While the groups say the new office will be essential to success of
Drugs
Two Shook, Hardy & Bacon attorneys say that a review of new Supreme Court justice Neil Gorsuch’s 10th Circuit Court of Appeals preemption appeals indicate that his appointment should help maintain the status quo as it relates to preemption jurisprudence. “More significantly,” they write in a Washington Legal Foundation
Drugs
FDA commissioner Scott Gottlieb says the agency will hold a 7/18 public meeting to solicit input on places where the agency’s rules, including the standards and procedures related to generic drug approvals, are being used in ways that may create obstacles to generic drug access instead of insuring
Drugs
Rep. Morgan Griffith (R-VA) has introduced the Preserving Patient Access to Compounded Medications Act of 2017 (H.R. 2871), that supporters say will improve access to compounded medicines. The measure addresses office-use compounding when authorized by state law and United States Pharmacopeia or National Formulary monograph requirements. It
Drugs
Sen. Charles Grassley (R-IA) says he and several colleagues have introduced the Creating and Restoring Access to Equivalent Samples (CREATES) Act (S. 974) to help FDA address REMS program abuse in which brand drug manufacturers restrict generic manufacturer access to samples for product testing and refuse to enter into
Drugs
FDA has approved a Shire NDA for Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprising three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Approval was based on data from 16 clinical studies evaluating
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 19-0 that the results of the LEADER trial establish that use of Novo Nordisk’s Victoza (liraglutide) in patients with Type 2 diabetes is not associated with excess cardiovascular risk. The 10/2016 sNDA requested inclusion of the
Drugs
An ongoing FDA/European Medicines Agency (EMA) pilot program on good clinical practice (GCP) inspections has shown promising results that could lead to greater harmonization and eventual mutual recognition of inspection reports, according to officials from the regulatory agencies. Speaking at a Drug Information Association session in Chicago 6/20,
Drugs
Critics say that aspects of a draft executive order on drug prices obtained by The New York Times would likely increase drug prices rather than bring any relief. One element in the draft targets the so-called 340B program that requires the drug industry to give discounts to hospitals and
Drugs
CDER has seen growing drug industry interest in its Emerging Technology Program, Center Office of Testing and Research director Lucinda Buhse told a Drug Information Association session in Chicago 6/20. She said CDER has accepted 32 industry requests to participate in the program over the past two years. She
Drugs
FDA has approved two Melinta Therapeutics NDAs for Baxdela (delafloxacin), indicated in adults for treating acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. The company describes Baxdela as a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus,
Drugs
FDA has issued Egalet Corp. a complete response letter on a prior approval supplement (PAS) for Oxaydo (oxycodone HCl, USP) tablets [Schedule C-II] in 10 mg and 15 mg dosage strengths. The agency letter requested more information about the effect of food on Oxaydo 15 mg and the intranasal
Drugs
An 11/28-12/1/16 FDA inspection at Qinhuangdao Zizhu Pharmaceutical Co., Beijing, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) according to a just-released 4/24 Warning Letter. Specific deviations included: * failing to prevent unauthorized access or changes to data,
Drugs
A 4/18-6/28/16 FDA inspection at Sewaren Innovative Pharmaceutical Packaging, Avenel, NJ, found that the firm failed to meet conditions required for exemption from some drug compounding regulations. A 5/22 Warning Letter from the agency’s New Jersey District Office says the investigator found that the
Drugs
FDA has issued a draft guidance with questions and answers providing guidance to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic records and electronic signatures in clinical investigations of medical products. The document clarifies, updates, and expands upon recommendations in a 2003
Drugs
FDA commissioner Scott Gottlieb has pledged to revamp the new drug development process for targeted drugs. Testifying before a Senate Appropriations subcommittee hearing 6/20, Gottlieb acknowledged that the “most tangible way we are going to reduce healthcare costs is by finding better treatments for a lot of costly diseases.
Drugs
Seattle Genetics says it is discontinuing its Phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia patients due to a higher rate of deaths seen in those on the therapy. The company made its decision after consulting with its independent data monitoring committee
Drugs
FDA has issued a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions. During user fee negotiations, the agency and industry agreed to pre-submission facility correspondence (PFC) to help obtain a shorter GDUFA goal date for priority ANDAs, their amendments, and prior approval supplements. The document
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Pharmacogenomic Data Submissions; OMB Control Number 0910–0557.” The guidance provides recommendations to sponsors submitting or holding INDs, NDAs, or BLAs on what pharmacogenomic data should be submitted during the drug development
Drugs
Alvogen has recalled seven lots of clindamycin injection USP ADD-Vantage Vials due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. The drug is indicated for treating serious infections caused by susceptible bacteria. Its use should
Drugs
FDA is alerting healthcare professionals about an ongoing shortage affecting several injectable drugs made by Pfizer’s Hospira unit, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), and emergency syringes of other drugs, including epinephrine, calcium chloride and atropine sulfate. Pfizer says the shortage is
Drugs
Advanced Pharma (also known as Avella of Houston) has recalled all unexpired lots of nitroglycerin products that were produced at its Houston location between 3/3 and 5/31. The recall is based on laboratory test results indicating a lower than expected potency on certain compounded lots of nitroglycerin injection,